BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY CYCLER

    MDR report key: 2625760 · Received June 13, 2012

    Report

    Report Number
    2937457-2012-00023
    Event Type
    Other
    Date Received
    June 13, 2012
    Date of Event
    May 15, 2012
    Report Date
    May 15, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ADVERSE EVENT AND NO PRODUCT PROBLEM IDENTIFIED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE DRAIN VOLUME MET THE CRITERIA FOR A REPORTABLE IIPV EVENT. (OTHER) - DEVICE INVESTIGATION IN PROGRESS. (B)(4).

    Description of Event or Problem · 1

    PT'S NURSE (B)(6) CALLED TECH SUPPORT REQUESTING A REPLACEMENT CYCLER DUE TO A REPORTED LARGE TOTAL UF DURING A CCPD TREATMENT. PT DRAINED 29 ML IN DRAIN 0 THEN BYPASSED TO FILL 1 = 1,997 ML. PT THEN STATED ONE OF THE 5 LITER SOLUTION BAGS WAS EMPTY. DRAIN 1 = 6,227 ML. FILL 2 = 1,348 ML AND DRAIN 2 = 3,707 ML. FILL 3 = 494 ML AND DRAIN 3 = 1,395 ML. TOTAL UF OF 7,489 ML. PER PD NURSE (B)(6), AT THE END OF THE TREATMENT BOTH SUPPLY BAGS WERE EMPTY. PT USES 2 BAGS OF 5 LITER PD SOLUTIONS FOR 3 FILLS OF 2,000 ML. ALARMS REPORTED: PT LINE, M65 SCALE READING ERROR WARNING, M31 AIR IN CASSETTE, FILL COMPLICATIONS, AND M65 SCALE READING ERROR. NO INFO ON WHAT PHASE THE ALARMS OCCURRED AT THIS TIME. PT STATED SHE "FIGURED OUT SHE WAS FILLED WITH TOO MUCH" WHEN SHE NOTICED THE SOLUTION BAG WAS EMPTY. PT DENIED PAIN OR DISCOMFORT DURING THIS EVENT. PER PD NURSE (B)(6), PT HAD NO SERIOUS INJURY AND DID NOT REQUIRE MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER PERITONEAL DIALYSIS CENTER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PD SOLUTIONS| LIBERTY CYCLER TUBING SET